Dutasteride

Product NDC
64380-763
11-digit product format
643800763
Labeler code
64380
Product ID
64380-763_44b80a39-9206-4f6f-82c5-12bb8ef0530e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dutasteride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA204262
Marketing category
ANDA
Marketing start
2016-12-09
Marketing end
0000-00-00
Substance
DUTASTERIDE
Active strength
1 mg/1
Pharmacologic classes
5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-763-04EA - Each64380-76323e83691-d92b-46c5-8dee-5ecd974cc6d712016-01-13
64380-763-05EA - Each64380-763c033d2ae-95ff-4058-80bb-9f785c160e5512016-01-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64380-763-046438007630430 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (64380-763-04) 2016-12-090000-00-00NoNoCurrent
64380-763-056438007630590 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (64380-763-05) 2016-12-100000-00-00NoNoCurrent